Field of the Invention
The present invention relates to drug reconstitution devices and, more particularly, to vial adapters for creating fluid communication between a cartridge and a vial to allow for reconstitution of a drug or medicament.
Description of Related Art
Certain drugs are preferably provided in powder or dry form (such as a lyophilized form), and require liquid reconstitution prior to administration to a patient. Lyophilized drugs, for example, typically are supplied in a freeze-dried form that must be mixed with a diluent to reconstitute the substance into a form that is suitable for injection.
In addition, drugs may be provided as multi-component systems which require mixing prior to administration. For example, a multi-component system may include one or more liquid (e.g., flowable) components and/or dry (e.g., powdered or granular) components which must be mixed prior to administration. Gondatopin and interferon are examples of such multi-component substances which are typically mixed just prior to being administered to a patient.
There are a number of devices and methods for drug reconstitution. The most common method is to supply a dry drug in a standard drug vial and have a medical practitioner reconstitute the drug prior to injection. The user uses a syringe to inject the diluent from one vial into a vial containing the dry drug. Next the user withdraws the reconstituted drug from the vial using a second syringe. The second syringe is used to inject the reconstituted drug into a patient. This reconstitution process is labor intensive and includes numerous opportunities for contamination of the needle and/or vial contents. Additionally, a user may accidently prick themselves or a patient with the needle while preparing the drug for reconstitution. These steps are even more intimidating for a patient attempting to self-inject a reconstituted drug for the first time.
Prior devices have also been developed that aid a user in aligning the needle of a syringe with the pierceable stopper of a vial containing the dry component of the drug. Often, the device further includes a shielding structure to prevent the user from being pierced by the needle during use.
There is a need for a reconstitution device with a safer and more accurate activation system which ensures that the needle mechanism will not be prematurely exposed or connected. Premature connection of either the drug or the diluent container to the transfer needle could lead to contamination of the drug and/or containers, or loss of drug. Unprotected exposure of the needle may also pose a safety risk.
There is also a need for a more user friendly needle advancement mechanism, which reduces the possibility of user error during the needle advancement process. It is important that the needle advancement mechanism allows for great flexibility in how and when the containers are attached to the adapter device. A further need exists for an arrangement which would allow the device to be provided: (1) as a pre-assembled kit in which the vial and cartridge come pre-attached to reduce user handling steps; (2) as a kit in which only the vial is attached; and/or (3) as a separate system in which the vial and container are attached by a user just prior to use.